OncoMatch/Clinical Trials/NCT06545682
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
Is NCT06545682 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Alpelisib + Pembrolizumab for melanoma (skin cancer).
Treatment: Alpelisib + Pembrolizumab — To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Melanoma
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
TNBC patients (defined as ER <1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative)
Required: HER2 (ERBB2) 0, 1+, 2+ and FISH negative (0, 1+, 2+ and FISH negative)
TNBC patients (defined as ER <1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative)
Disease stage
Metastatic disease required
locally advanced, unresectable, or metastatic melanoma or TNBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Melanoma patients ... who have progressed on an anti-PD-1 or anti-PD-L1-based regimen
Must have received: anti-PD-L1 therapy
Melanoma patients ... who have progressed on an anti-PD-1 or anti-PD-L1-based regimen
Cannot have received: chemotherapy or radiotherapy
Exception: within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment
Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment
Lab requirements
Blood counts
Adequate organ function as defined in Table 2
Kidney function
Adequate organ function as defined in Table 2
Liver function
Adequate organ function as defined in Table 2
Has adequate organ function as defined in Table 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06545682 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy or radiotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression <1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 0, 1+, 2+ and FISH negative is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify